FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN MANAGEMENT SYSTEM

MDR report key: 8866236 · Received August 6, 2019

Report

Report Number: 3004464228-2019-07266
Event Type: Malfunction
Date Received: August 6, 2019
Date of Event: June 1, 2019
Report Date: June 1, 2019
Manufacturer: INSULET CORPORATION
Product Code: LZG
UDI-DI: 20385081120033
PMA / PMN Number: K162296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION FOUND SUBSTANTIAL DAMAGE TO THE UPPER AND LOWER HOUSING, FORMED NEEDLE, SOFT CANNULA, PCB, NEEDLE MECHANISM, AND COMMUTATOR CAP. DATA WAS UNABLE TO BE RECOVERED FROM THE DEVICE. ALTHOUGH SIGNIFICANT DAMAGE WAS PRESENT, THE CAUSE AND TIMING COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S BG (BLOOD GLUCOSE) LEVELS REACHED 250-310 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. FOR TREATMENT, GAVE AN INJECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
659126	OMNIPOD INSULIN MANAGEMENT SYSTEM	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L44220	20385081120033

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR